Methadone for Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

Efficacy Methadone for Management Postoperative Pain After the Use of Anesthesia Intravenous in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833715
• Other study ID #: P03/13
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2023
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of methadone versus morphine in dealing with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than morphine for postoperative pain treatment.

Description:

Patients undergo laparoscopic cholecystectomy at Almirante Nef Naval Hospital will be recruited, between March and July 2013. The sample size was calculated to obtain an average difference of 4 mg of morphine (DE 1.5) to 3 mg of morphine (DE 1.5), with a power of 80% and a significance level of 0.05. This came down to 36 randomized patients into each group, so 86 patients will be recruited considering a 15% loss to follow up.

Before signing an informed consent, we will explain to them how to classify pain intensity numerical rating scale (NRS) and this will be evaluated periodically during the first 24 hours after surgery.

General anesthesia will be based on Remifentanil and Propofol, titrated to achieve bispectral index (BIS) between 40 and 60. Patients will be randomized into methadone group (ME) and morphine group (MO), they will receive 0.08 mg / kg bolus of methadone or 0.08 mg / kg bolus of morphine as applicable at the time of beginning surgery. Postoperative analgesia will be standard for both groups. Patient´s demographic data will be filed as well as surgical timings.

All patients will remain in the anesthetic recovery room for the first two hours , to get a record taken of vital signs and measurement of NRS at 5, 15, 30, 60 and 120 minutes. If NRS is greater than or equal to 4, 1 mg of morphine ev will be used as analgesic rescue. In room measuring NRS continue hospitalized at 4, 8, 12 and 24 hours postoperatively and were used as rescue analgesia if ketorolac 30mg ev NRS is greater than or equal to 4. The amount of morphine is registered and ketorolac rescue of both groups as well as pain assessment scores. The occurrence of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is also recorded in both groups, to be compared later as a secondary objective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients undergoing laparoscopic cholecystectomy in the Almirante Nef Naval Hospital

• Patients ASA 1 or 2

Exclusion Criteria:

• Patients with renal insufficiency (creatinine> 2.0 mg / dl)

• Patients with a history of liver failure

• Patients with BMI> 35 kg/m2

• Patients with hypersensitivity to the drugs in question

• History of chronic use of opioids

• Need for conversion to open surgery

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Morphine
Morphine group,receive morphine 0.08 mg / kg at the start of surgery
• Methadone
Methadone group,receive methadone 0.08 mg / kg at the start of surgery
• TIVA
TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.

Locations

Country	Name	City	State
Chile	Almirante Nef Naval Hospital	Viña del Mar	Valparaiso

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Valparaiso

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Arriaza N, Papuzinski C, Kirmayr M, Matta M, Aranda F, Stojanova J, Madrid E. Efficacy of methadone for the management of postoperative pain in laparoscopic cholecystectomy: A randomized clinical trial. Medwave. 2021 Mar 23;21(2):e8135. doi: 10.5867/medwave.2021.02.8134. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The different of the adverse effect	The total number of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is recorded in both groups, to be compared later as a secondary objective.	First 24 hours postoperatively
Primary	Difference in milligrams of morphine used as rescue analgesia	Difference in milligrams of morphine used as rescue analgesia in postoperative period in both groups	First 24 hours postoperatively
Secondary	Difference in pain scores, using the Numeric Rating Scale	Difference in pain scores, using the Numeric Rating Scale at 5, 15, 30, 60 and 120 minutes postoperative. Also at 4, 8, 12 and 24 hours postoperatively, during hospitalization.	First 24 hours postoperatively